Immunoassay Market Size, Top Share To 2034

(MENAFN- Straits Research) Introduction

The global immunoassay market size was estimated at USD 28.29 billion in 2025 and is anticipated to grow till USD 42.43 billion in 2034 at a CAGR of 4.64% from 2026-2034.

The global immunoassay market is primarily growing due to rising disease prevalence, demand for accurate diagnostics, and technological advancements.

Market Dynamics The rising prevalence of chronic and infectious diseases worldwide drives the global market growth

The global immunoassay market is primarily driven by the rising prevalence of chronic and infectious diseases, creating strong demand for reliable diagnostic solutions.

• Chronic conditions account for nearly 74% of global deaths, according to the WHO. Additionally, as of May 2025, the global SARS-CoV-2 test positivity rate reached 11%, reflecting a resurgence of COVID-19 cases.

Immunoassays, with high sensitivity and specificity, are vital for early detection, disease monitoring, treatment guidance, and improving patient outcomes worldwide.

Expanding immunoassay applications in veterinary diagnostics creates tremendous opportunities

Veterinary diagnostics is becoming a key growth avenue for immunoassays, driven by the rising incidence of companion animal diseases and increasing pet healthcare spending. Immunoassay-based tests provide veterinarians with accurate, rapid, and minimally invasive diagnostic solutions for conditions ranging from infectious diseases to cancer.

• For instance, in March 2025, VolitionRx partnered with Fujifilm Vet Systems to automate its Nu. Q Vet Cancer Test in Japan, enhancing speed and scalability for cancer screening in pets.

As demand for advanced veterinary diagnostics rises globally, immunoassays are poised to play a pivotal role.

Regional Insights

North America is expected to be the market leader in immunoassays. Early screening can help with the early detection and prevention of these life-threatening diseases.

Europe is predicted to overtake the United States as the world's second-largest immunoassay market. The rising cancer disease burden and strong government policies aimed at lowering chronic disease rates are to blame.

The Asia-Pacific immunoassay market is expected to expand rapidly.

Growing medical treatment for infectious and chronic diseases due to increased development and production of vaccines and drugs.

In Latin America, although government health expenditures are tiny in comparison to those in developed economies, the region is expected to continue to grow. There are also several cancer-awareness programs available

Key Highlights

• By product, the market is segmented into reagents and kits, analyzers, and software and services. The software and services segment accounted for 16.02% of the revenue share and is projected to grow at the fastest pace, fueled by increasing demand for efficient data management and workflow optimization solutions.
• By technology , the market is segmented into ELISA, rapid tests, Western blotting, radioimmunoassay, and other technologies. The rapid tests segment is estimated to grow at the fastest pace with a CAGR of 5.04%, fueled by increasing adoption of point-of-care and home-based diagnostics.
• By specimen , the market includes blood, saliva, urine, and other specimen types. The urine segment is estimated to grow at the fastest pace with a CAGR of 5.32%, supported by its non-invasive collection method and expanding applications in disease diagnostics.
• By application , the market is divided into infectious diseases, endocrinology, oncology, bone and mineral disorders, cardiology, blood screening, autoimmune disorders, allergy diagnostics, toxicology, and other applications. The oncology segment is estimated to grow at the fastest pace with a CAGR of 5.51%, propelled by rising cancer prevalence and growing reliance on biomarker-based diagnostics.
• By end-user , the market is segmented into hospitals, clinical laboratories, pharmaceutical and biotechnology companies and CROs, blood banks, research and academic laboratories, home care settings, and others. The clinical laboratories segment is estimated to grow at the fastest pace with a CAGR of 5.02%, owing to expanding testing volumes, automation adoption, and advanced diagnostic capabilities.
• Asia-Pacific is estimated to be the fastest-growing region in the global market, with a CAGR of 5.9%. This growth can be attributed to the growing due to rising healthcare expenditure, expanding diagnostic infrastructure, increasing disease prevalence, government initiatives, and growing adoption of advanced immunoassay technologies.

Competitive Players

The key players in the global market are Abbott Laboratories, F. Hoffmann-La Roche Ltd., Siemens Healthineers, Danaher Corporation (Beckman Coulter), Thermo Fisher Scientific Inc., bioMérieux SA, QuidelOrtho Corporation, Becton, Dickinson and Company (BD), Bio-Rad Laboratories Inc., PerkinElmer Inc., Sysmex Corporation, Agilent Technologies Inc., Merck KGaA, DiaSorin S.p.A., Mindray Medical International Limited, Labcorp, and others.

Recent Developments

• In March 2025, Beckman Coulter Diagnostics, part of Danaher Corporation, received FDA 510(k) clearance for the DxC 500i Clinical Analyzer, an integrated immunoassay and chemistry system, offering advanced technology and a user-friendly interface to support laboratories in addressing increasing healthcare demands.

Segmentation

By Product

Reagents & Kits

ELISA Reagents & Kits

Rapid Test Reagent & Kits

ELISpot Reagents & Kits

Western Blot Reagents & Kits

Other Reagents & Kits

Analyzer

Open-ended System

Closed-Ended System

Software and Services

By Technology

ELISA

Rapid Tests

Western Blotting

Radioimmunoassay

Other technologies

By Specimen

Blood

Saliva

Urine

Other Specimen

By Application

Infectious diseases

Endocrinology

Oncology

Bone and mineral disorders

Cardiology

Blood screening

Autoimmune Disorders

Allergy Diagnostics

Toxicology

Other Application

By End-User

Hospitals

Clinical Laboratories

Pharmaceutical & Biotechnology Companies and CRO

Blood Banks

Research & Academic Laboratories

Home Care Setting

Others

By Regions

North America

Europe

Asia-Pacific

Latin America

The Middle East and Africa

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